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Synapse-trial.com

FACT SHEET: BHR-100: A Novel Intravenous Progesterone Infusion
for Treating Traumatic Brain Injury

Traumatic brain injury (TBI) is a serious public health problem that affects more than 3.5 million
people each year in the United Statesand is a major cause of death and disability worldwide.
Despite significant research resulting in more than 75 clinical trials over the past 20 years, there
is still no approved treatment for TBI.
BHR Pharma is sponsori, a global Phase III clinical trial studying investigational
agent BHR-100 for the acute treatment of severe TBI, with the intent of bringing the first-ever
TBI treatment to market.
BHR-100: A Neuroprotective Agent
• BHR-100 is a novel intravenous progesterone infusion formulation
• Research has shown that administering large doses of progesterone during the first few hours to days after injury could significantly limit brain damage, reduce loss of neuronal tissue, and improve functional recovery • BHR-100 must be administered within eight hours of injury and infused continuously over five days (an initial loading dose is 0.71 mg/kg for the first hour followed by 0.5 mg/kg/hr for the remaining 119 hours) • BHR-100 is stable at controlled room temperatures and has a shelf life of 30 months, which eliminates the need for on-site compounding • In 2009, the U.S. Food and Drug Administration granted BHR-100 an Orphan Drug designation for treating moderate and severe TBI and placed the drug on Fast Track status designed to accelerate its potential approval • The European Medicines Agency granted an orphan medicinal product designation for treating moderate and severe TBI to BHR-100 in early 2013
SyNAPSe® (Study of the Neuroprotective Activity of Progesterone in Severe Traumatic
Brain Injuries)
• SyNAPSe is the only FDA-approved Phase III clinical trial designed to treat patients with
• Patients are followed for six months, at which point they are evaluated using the Glasgow Outcome Scale, the primary study endpoint which evaluates the patients’ outcome • More than 150 sites in 21 countries are participating in the trial with teams led by the top • The trial has enrolled more than 1,150 of the 1,195 patients needed to complete the trial, and anticipates completing study enrollment by Aug. 2013 • The study's independent Data and Safety Monitoring Board has met four times to review patient data and concluded the study should continue to its intended conclusion at the end of each meeting 1 Coronado VG, McGuire LC, Sarmiento K, et al. Trends in traumatic brain injury in the U.S. and the public health response: 1995-2009. J Safety Res. 2012;43(4):299- 2 Faul M, Xu L, Wald MM & Coronado VG. (2010). Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations and Deaths 2002–2006. Centers for Disease Control and Prevention, National Center for Injury Prevention and Control 3Goss CW, Hoffman SW, Stein DG (2003). Behavioral effects and anatomic correlates after brain injury: a progesterone dose-response study. Pharmacol Biochem Progesterone
• Progesterone – also known as P4 (pregn-4-ene-3,20-dione) – is a 21-carbon steroid
hormone known principally for its involvement in the female menstrual cycle, pregnancy (pro-gestation) and embryogenesis of humans • Progesterone belongs to a class of hormones calland is the major naturally • Progesterone is a potent, naturally occurring neurosteroid hormone produced in both male • Progesterone receptors are abundant and widely distributed in the male and female central • Unlike other sex steroids such as estrogen, progesterone is not only synthesized in the gonads and adrenal glands, but also produced by glial cells in the brain and by Schwann cells in the peripheral nervous system • Allopregnanolone, a metabolite of progesterone preferentially produced in the CNS, has been shown to be an active neuroprotectant molecule. • Research has shown that progesterone exerts its neuroprotective effects by protecting or rebuilding the blood-brain barrier, decreasing development of cerebral edema (brain swelling), down-regulating the inflammatory cascade and limiting cellular necrosis and apoptosis (programmed cell death)
Additional Research Supporting Progesterone for Traumatic Brain Injury
• Animal and Phase II studies have shown progesterone to have neuroprotective and
• Discovery of progesterone's neuroprotective properties began with the observation of a gender difference in the model responses of mice to experimentally induced TBI. After noting anecdotal reports that female rats recover better than male rats following TBI, researcher Donald Stein, Ph.D. and his co-workers conducted studies which showed that the hormone might account for this discrepancy • Previous clinical trials conducted in the U.S. (ProTECT) and China (Xiao et al) suggests that progesterone can improve outcomes for people with TBI. The studies demonstrated about a 50 percent lower mortality in the progesterone-treated group as compared to placebo, and the Chinese study showed statistically significant functional improvement[][] • An NIH-sponsored phase III clinical trial known as ProTECT III is currently studying the safety and efficacy of progesterone for moderate to serve TBI patients. While this study builds on research evaluating progesterone’s role as a neuroprotective agent, it is not designed to lead to an approved treatment 4 Stein DG, et al. (2008). Progesterone exerts neuroprotective effects after brain injury. Brain Res Rev 57: 386-397. 5 Stein DG, Wright DW, Kel erman AL (2008). Does progesterone have neuroprotective properties? Ann Emerg Med; 51(2): 164–72. 6 Stein DG, et al. (2008). Progesterone exerts neuroprotective effects after brain injury. Brain Res Rev 57: 386-397. 7 Wright DW, et al. (2007). ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg Med 49: 391-402, 402.e1-2. 8 Xiao, G., Wei, J., Yan, W., Wang, W., & Lu, Z. (2008). Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Critical Care, 12, R61 9 Stein DG, et al. (2008). Progesterone exerts neuroprotective effects after brain injury. Brain Res Rev 57: 386-397, 10 Xiao, G., Wei, J., Yan, W., Wang, W., & Lu, Z. (2008). Improved outcomes from the administration of progesterone for patients with acute severe traumatic brain injury: a randomized controlled trial. Critical Care, 12, R61 11 Wright DW, Kel ermann AL, Hertzberg VS, Clark PL, Frankel M, Goldstein FC, Salomone JP, Dent LL, Harris OA, Ander DS, Lowery DW, Patel MM, Denson DD, Gordon AB, Wald MM, Gupta S, Hoffman SW, Stein DG. (2007). ProTECT: a randomized clinical trial of progesterone for acute traumatic brain injury. Ann Emerg 12 Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment: Phase III Clinical Trial. (n.d.). ProTECT III Index. Retrieved May 2, 2012, from
BHR Pharma, LLC
is a global pharmaceutical research and development organization with an
emphasis on developing treatments for unmet and underserved medical needs. BHR is located
in Herndon, VA and is a wholly owned subsidiary of a Besins family-owned
business headquartered in Bangkok, Thailand.

Source: http://www.synapse-trial.com/downloads/FSBHR-100.pdf

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Effect of intensive blood-glucose control with metformin oncomplications in overweight patients with type 2 diabetes (UKPDS34). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12; 352(9131): 854-65. BACKGROUND: In patients with type 2 diabetes, intensive blood-glucose control with insulin or sulphonylurea therapy decreasesprogression of microvascular disease and may also reduce th

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